Apparatus and method for forming an opening in patient&#39;s tissue

ABSTRACT

A surgical instrument system for use in a surgical procedure is disclosed. The surgical instrument system may include an instrument configured to puncture the tissue of a patient and detect when the instrument has entered a lumen of the patient&#39;s body. Liquid may be present in the lumen or the lumen may be devoid of liquid or tissue. The instrument is configured to determine when the needle tip is engaged with a portion of patient&#39;s tissue and determine when the needle tip has exited that portion of the patient&#39;s tissue by detecting changes in properties of the tissue, specifically, electrical resistance.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. patent application Ser. No.15/452,323, filed Mar. 7, 2017, and claims the benefit of U.S.Provisional Patent Application No. 62/304,756, filed Mar. 7, 2016, andof U.S. Provisional Patent Application No. 62/364,812, filed Jul. 20,2016, the entireties of each of which are incorporated herein byreference.

Cross-reference is made to U.S. patent application Ser. No. 14/996,426,filed Jan. 15, 2016, and to International Application No.PCT/US16/13528, filed Jan. 15, 2016, the entireties of each of which areincorporated herein by reference.

TECHNICAL FIELD

The present disclosure relates to instruments for forming and dilatingan opening in a patient's tissue and, more specifically, for dilating anopening through a tracheal wall of a patient.

BACKGROUND

There are a number of techniques for establishing an adequate airpassageway for a patient. When the trachea, nostrils and/or mouth arefree of obstruction, endotracheal intubation, which involves theinsertion of a tube through the nostrils or mouth and into the tracheaitself, may be used. One endotracheal tube system for use inendotracheal intubation is described in International Patent ApplicationPublication No. WO2014/088904, which is incorporated herein byreference.

Another technique for establishing an adequate air passageway involvesthe creation of a puncture or incision in the tracheal wall. Atracheostomy tube may then be inserted through the opening to form apassageway that effectively bypasses the upper trachea, nostrils and/ormouth. The initial incision may be made with a smaller needle and thenenlarged or dilated to receive the tracheostomy tube.

Various techniques and devices for creating punctures or other incisionsin the soft issue of a patient are illustrated and described in: “AnEndoscopic Technique for Restoration of Voice After Laryngectomy,”Annals of Ontology, Rhinology And Laryngology, Singer et al., 89:529-533, 1980, “Tracheoesophageal Puncture,” Atlas of TransnasalEsphagoscopy, Postma, et al., 2007, Tracheoesophageal Puncture in theOffice Setting with Local Anesthesia, Annals of Ontology, Rhinology AndLaryngology, Desyatnikova et al., 110, 613-616, 2001, A FailsafeTechnique For Tracheoesophagal Puncture, Koch, The Laryngoscope, 111,September 2001, A New Method For Tracheoesophagal Puncture Under TopicalAnesthesia, Gross et al., The Laryngoscope, 104, February 1994, and theBlom-Singer® Voice Prosthesis Placement Surgical Kit available fromInhealth® Technologies. Another device for use with the soft tissue of apatient is the BD Angiocath Autoguard Shielded IV Catheter, which iscommercially available from Becton, Dickinson and Company of New Jersey.

There are also the devices and methods illustrated and described in U.S.Pat. Nos. 5,653,230; 5,217,005; and 8,696,697; and U.S. Pat. App. Pub.No. 2012/0180787. The disclosures of these references are herebyincorporated herein by reference. Another device and method is shown inU.S. Pat. No. 6,603,997. This listing is not intended as arepresentation that a complete search of all relevant prior art has beenconducted, or that no better references than those listed exist.

SUMMARY

According to one aspect, a surgical instrument system comprises ahousing including a handle, a shaft extending outwardly from the housingto a distal end configured to form a puncture in a patient's tissue, aconductor plate positioned in the shaft, a retraction mechanism operableto move the distal end of the shaft in a first direction toward thehousing, and a controller positioned in the housing. The controller isconfigured to energize a sensor circuit including a section of the shaftand the conductor plate, and monitor an electrical signal received fromthe sensor circuit. When an electrical resistance value based on themonitored electrical signal is greater than a predetermined threshold,the controller is configured to activate an indicator, and energize theretraction mechanism to move the distal end of the shaft in a directiontoward the housing.

In some embodiments, the predetermined threshold for the resistancevalue may be greater than or equal to 100 kilo-ohms.

In some embodiments, the conductor plate may be positioned in an openingdefined in the distal end of the shaft. Additionally, in someembodiments, the conductor plate may be a metallic inner shaftpositioned in a passageway defined in the outer shaft.

In some embodiments, the system may comprise a non-conductive filmpositioned in the opening defined in the distal end of the shaft betweenthe conductor plate and the shaft that electrically isolates theconductor plate from the shaft. Additionally, in some embodiments, thenon-conductive film may include an annular ring that surrounds theconductor plate. In some embodiments, the non-conductive film mayinclude a cylindrical ring that is positioned in a passageway defined inthe outer shaft between a metallic inner shaft of the conductor plateand the outer shaft. In some embodiments, the annular ring orcylindrical ring may have a thickness of 0.5 millimeters. Thenon-conductive film may be formed from a non-conductive plastic orsilicone material.

In some embodiments, the indicator is a visual indicator. Additionally,in some embodiments, the controller may be configured to determinewhether the distal end has engaged tissue of a patient based on theelectrical signal received from the sensor circuit, energize theindicator in a first state when the controller has determined that thedistal end has engaged tissue of the patient, and energize the indicatorin a second state to activate the indicator when the controller hasdetermined that the distal end has penetrated the lumen of the patient.In some embodiments, the second state is different from the first statesuch that a user may determine whether the instrument is armed and/orhas penetrated the lumen.

In some embodiments, when the resistance value based on the monitoredelectrical signal is less than a predetermined value for a predeterminedperiod of time, the controller may be configured to energize theindicator in a first state to indicate the instrument is armed.Additionally, in some embodiments, the predetermined value may be in arange of 1 kilo-ohm to 100 kilo-ohms In some embodiments, thepredetermined period of time may be equal to 200 milliseconds.Additionally, in some embodiments, the instrument may include a switchoperable to be toggled by a user to disarm the instrument.

In some embodiments, the first state may be one of a flashing light anda continuous light, and the second state may be the other of a flashinglight and a continuous light. It should be appreciated that in someembodiments the first state may include flashing the indicator at afirst frequency, and the second state may include flashing the indicatorat a second frequency different from the first frequency.

In some embodiments, the retraction mechanism may include a linearactuator that is electrically-operated. Additionally, in someembodiments, the shaft may be operable to move along a first axis, andthe linear actuator may be operable to move along a second axisextending orthogonal to the first axis to cause the shaft to move alongthe first axis.

In some embodiments, the shaft may extend from the distal end to aproximal end positioned in the housing, and the retraction mechanismincludes a mounting frame secured to the proximal end of the shaft.

Additionally, in some embodiments, the retraction mechanism may includea locking arm operable to rotate about a pivot pin between a firstposition in which a proximal end of the mounting frame is engaged with afirst surface of the locking arm and a second position in which theproximal end of the mounting frame is received in a passageway definedin the shaft. In some embodiments, the linear actuator is operable toadvance into contact with the locking arm to cause the locking arm torotate between the first position and the second position.

In some embodiments, the retraction mechanism may further comprise abiasing element attached to an end of the locking arm, and the biasingelement may be operable to bias the locking arm in the first position.

In some embodiments, the mounting frame may include a mounting bracketthat has a first end secured to the shaft and a second, opposite endsecured to an elongated rod, and the elongated rod may include theproximal end of the mounting frame.

In some embodiments, the locking arm may include a sleeve that includesthe first surface. Additionally, in some embodiments, retractionmechanism may further comprise a biasing element operable to urge theshaft in the first direction, and the biasing element may be positionedbetween a plate of the mounting frame and a wall of the housing.

According to another aspect, a method for performing a surgicalprocedure is disclosed. The method includes inserting a needle tip of asurgical instrument into a patient's tissue, advancing the needle tipthrough the tissue, monitoring an indicator of the surgical instrumentwhile advancing the needle tip through the tissue, and maintaining aposition of the surgical instrument in response to the indicatorindicating the needle tip has entered a target lumen of the patient.

In some embodiments, the surgical instrument may be operable toautomatically retract the needle tip when the needle tip has entered thetarget lumen of the patient. Additionally, in some embodiments, thesurgical instrument may include a control circuit operable to measure achange in electrical resistance to determine when the needle tip hasentered the target lumen of the patient and activate the indicator toindicate the needle tip has entered a target lumen of the patient.

According to another aspect, a method of performing a surgical procedurecomprises energizing a sensor circuit of a surgical instrument includinga needle tip configured for insertion into a patient's tissue,monitoring an electrical signal received from the sensor circuit,energizing an indicator in a first state when a resistance value basedon the electrical signal is less than a predetermined valuecorresponding to the needle tip being positioned in the patient'stissue, energizing the indicator in a second state when the resistancevalue based on the electrical signal is greater than a predeterminedthreshold corresponding to the needle tip being positioned in apatient's lumen, and energizing a retraction mechanism of the surgicalinstrument to move the needle tip away from the patient's lumen.

In some embodiments, the method may further comprising activating atimer when the resistance value based on the electrical signal is lessthan a predetermined value. The step of energizing the indicator in thefirst state may include energizing the indicator in the first stateafter a predetermined amount of time has elapsed from the activation ofthe timer.

In some embodiments, the method may further include activating a timerwhen the resistance value based on the electrical signal is greater thana predetermined threshold. The step of energizing the retractionmechanism of the surgical instrument may include energizing theretraction mechanism of the surgical instrument after a predeterminedamount of time has elapsed from the activation of the timer.

Additionally, in some embodiments, the surgical instrument may includean elongated shaft, and the sensor circuit may include a portion of theshaft and a conductor plate or shaft positioned in the shaft. In someembodiments, the sensor circuit may include a pair of conductor plates,and the elongated shaft may be formed from a non-conductive material.

According to another aspect of the disclosure, a surgical instrumentsystem for detecting a lumen in a patient's body is disclosed. When theinstrument determines that the needle tip has entered the target lumen,the instrument may then activate an indicator such as, for example, aflashing light emitting diode (LED) in the instrument to alert theoperator to not advance further. In one embodiment, the instrument mayalso be programmed to instantaneously retract its tip a distance of, forexample, about 8 mm In other embodiments, the tip of the instrument mayremain stationary to facilitate fluid infusion or suction. In someembodiments, the system may include a noncompliant dilation balloon on acatheter for use in procedures such as, for example, percutaneoustracheostomy or percutaneous gastrostomy. In some embodiments, thesurgical instrument may be another cutting tool such as, for example, acutting blade in which the entire blade but a portion of the cuttingedge may be insulated.

According to another aspect, a method for performing a surgicalprocedure comprises inserting a needle tip of a surgical instrument intoa patient's tissue, advancing the needle tip through the tissue,monitoring an indicator of the surgical instrument while advancing theneedle tip through the tissue, and maintaining a position of thesurgical instrument in response to the indicator indicating the needletip has entered a target lumen of the patient.

Illustratively according to this aspect, the surgical instrument may beoperable to automatically retract the needle tip when the needle tip hasentered the target lumen of the patient.

According to another aspect, a method for performing a surgicalprocedure comprises energizing an indicator of a surgical instrument toprovide a first indication to a user when a needle tip is engaged with aportion of patient's tissue and energizing the indicator to provide asecond indication different from the first indication in response to theneedle tip exiting the portion of the patient's tissue.

Illustratively according to this aspect, the method may further compriseautomatically retracting the needle tip in response to the needle tipexiting the portion of the patient's tissue.

Illustratively according to this aspect, energizing the indicator toprovide the second indication different from the first indication inresponse to the needle tip exiting the portion of the patient's tissueincludes energizing the indicator when the needle tip has entered thetarget lumen of the patient.

Illustratively according to this aspect, energizing the indicator toprovide the second indication different from the first indication inresponse to the needle tip exiting the portion of the patient's tissueincludes energizing the indicator when the needle tip has enteredanother portion of the patient.

According to another aspect, a dilation instrument system is disclosed.The dilation instrument system includes a percutaneous dilation balloonand a moveably positionable retainer. The percutaneous dilation balloonis included in a balloon catheter configured to be positioned in anopening defined in a tracheal wall of a patient. The catheter includes asheath having a proximal end and a distal end, the balloon extendingover the sheath between the proximal end and the distal end, and adeflectable retention flange secured to the distal end of the sheath.The retainer is positioned over the balloon and is configured to moverelative to the balloon such that upon inflation of the balloon when theballoon is positioned in the opening in the tracheal wall, the retainerengages the tracheal wall to inhibit movement of the balloon catheter.

According to another aspect, a dilation instrument system comprises apercutaneous dilation balloon, a stationary deflectable retentionflange, and a moveably positionable retainer. The retainer is positionedover the balloon and is configured to move relative to the balloon suchthat upon inflation of the balloon when the balloon is positioned in anopening in a wall of the patient's tissue, the retainer is positionedadjacent to the wall to inhibit movement of the balloon catheter.

In some embodiments, the inflatable balloon may have a maximum diameterwhen inflated, and the retainer may include an annular body having aninner diameter that is less than the maximum diameter of the inflatableballoon. Additionally, in some embodiments, the annular body may includea first collar extending in a first direction, a second collar extendingoutwardly in a second direction opposite the first direction, and apassageway extending between an opening defined in the first collar andan opening defined in the second collar. The passageway may define theinner diameter of the annular body.

In some embodiments, the sheath may comprise a tip positioned at thedistal end and that is formed from a first material. The sheath maycomprise an elongated body extending from the tip to the proximal end.The elongated body may be formed from a second material that is harderthan the first material.

In some embodiments, the dilation instrument system may further comprisea surgical instrument configured to be coupled to the balloon catheter.The surgical instrument may comprise an elongated shaft sized to bepositioned in a lumen defined in the sheath and a needle tip configuredto puncture the tracheal wall. The needle tip may be configured toextend outwardly from the distal end of the sheath when the surgicalinstrument is coupled to the balloon catheter.

In some embodiments, the surgical instrument of the dilation instrumentsystem may further comprise a handle coupled to the elongated shaft, anindicator including a light source in the handle, and a sensor operableto energize the light source when the needle tip penetrates a lumen ofthe patient's trachea.

In some embodiments, the surgical instrument of the dilation instrumentsystem may comprise a retraction mechanism operable to automaticallyretract the needle tip after the needle tip penetrates the lumen of thepatient's trachea.

According to another aspect, a surgical instrument system comprising acatheter having a lumen defined therein, the catheter further includinga distal tip formed from a first material and an elongated bodyextending from the distal tip to an opposite proximal end, the elongatedbody being formed from a second material that has a hardness greaterthan the first material.

According to another aspect, a method of dilating an opening in apatient's tissue is disclosed. The method comprises advancing a distalend of a balloon catheter in a first direction through the opening inthe patient's tissue, pulling the balloon catheter in a second directionopposite the first direction to engage a retention flange secured to thedistal end with an inner surface of the patient's tissue, advancing aretainer along the balloon catheter in the first direction to engage anouter surface of the patient's tissue opposite the inner surface, andinflating a balloon of the balloon catheter to dilate the opening in thepatient's tissue.

According to another aspect, a method of dilating an opening in apatient's tissue comprises positioning an uninflated dilation balloon inthe opening in the patient's tissue, engaging a retention flange with aninner surface of the patient's tissue, advancing a moveable retaineralong the balloon to a position adjacent to an outer surface of thepatient's tissue opposite the inner surface, and inflating the balloonto dilate the opening in the patient's tissue.

In some embodiments, the method may further comprise positioning anelongated shaft of a surgical instrument in a lumen defined in theballoon catheter such that a needle tip of the surgical instrumentextends outwardly from the distal end of the balloon catheter, insertingthe needle tip of the surgical instrument into the outer surface of thepatient's tissue, and advancing the needle tip through the tissue todefine the opening.

In some embodiments, the surgical instrument may be operable toautomatically retract the needle tip into the lumen of the ballooncatheter when the needle tip has penetrated the inner surface of thetissue.

In some embodiments, the method may further comprise monitoring anindicator of the surgical instrument while advancing the needle tipthrough the tissue. The surgical instrument may be operable toautomatically retract the needle tip in response to the indicatorindicating the needle tip has penetrated the inner surface of thetissue. Additionally, in some embodiments, the indicator may be operableto provide a visual indication when the needle tip has penetrated theinner surface of the tissue.

In some embodiments, advancing the retainer along the balloon catheterin the first direction may include engaging an annular body of theretainer with the outer surface of the tissue.

According to another aspect, a dilation instrument system is disclosed.The system comprises a balloon catheter configured to be positioned inan opening defined in a patient's tissue. The catheter includes a sheathhaving a proximal end and an elastomeric distal end, an inflatableballoon extending over the sheath between the proximal end and thedistal end, and a deformable retention flange secured to the distal endof the sheath. The system also includes a retainer positioned over theballoon and configured to move relative to the balloon such that uponinflation of the balloon when the balloon is positioned in the openingin the patient's tissue, the retainer engages the patient's tissue toinhibit movement of the balloon catheter. The system also includes asurgical instrument removably coupled to the sheath. The surgicalinstrument comprises a needle tip extending outwardly from the sheaththat is configured to puncture the patient's tissue. The surgicalinstrument may further comprise a retraction mechanism operable toautomatically retract the needle tip after the needle tip penetrates alumen of the patient's tissue. Additionally, the sheath may comprise atip positioned at the distal end that is formed from a first material,and an elongated body extending from the tip to the proximal end of thesheath. The elongated body may be formed from a second material that isharder than the first material, and the retraction mechanism is operableto retract the

According to another aspect, a surgical instrument system comprises anelongated body including a handle and a shaft extending from the handleto a distal end configured to pass through a patient's tissue, anindicator, a sensor operable to generate an electrical signal, and acontrol circuit. The control circuit is configured to receive theelectrical signal from the sensor, determine whether the distal end haspenetrated a lumen of a patient, and activate the indicator when thedistal end has penetrated the lumen of the patient.

In some embodiments, the control circuit may be configured to determinewhether the distal end has engaged tissue of a patient, energize thelight source in a first state when the distal end has engaged tissue ofthe patient, and energize the light source in a second state when thedistal end has penetrated the lumen of the patient. The second state maybe different from the first state. Additionally, when the light sourceis in the first state, the light source may be flashing.

In some embodiments, the system may further comprise a retractionmechanism operable to retract the distal end. The control circuit may beconfigured to energize the retraction mechanism when the distal end haspenetrated the lumen of the patient.

In some embodiments, the retraction mechanism may include a biasingelement configured to bias the distal end in a retracted position. Insome embodiments, the retraction mechanism may include a locking armconfigured to maintain the distal end in an extended position.

In some embodiments, the control circuit may be configured to determinewhether the distal end has engaged tissue of a patient, energize thelight source in a first state when the distal end has engaged tissue ofthe patient, and energize the light source in a second state when thedistal end has penetrated the lumen of the patient, the second statebeing different from the first state. In some embodiments, the systemmay further comprise a retraction mechanism operable to retract thedistal end. The control circuit may be configured to energize theretraction mechanism when the distal end has penetrated the lumen of thepatient.

In some embodiments, the sensor may include an outer surface of theshaft electrically connected to the control circuit and a first platepositioned at the distal end of the shaft. The first plate may beelectrically connected to the control circuit.

Additionally, in some embodiments, the control circuit may be operableto apply an electrical charge to the first plate. In some embodiments,the sensor may be operable to measure changes in electrical propertiesof the patient's tissue.

In some embodiments, the sensor may be operable to measure changes inresistance.

According to another aspect, a method for performing a surgicalprocedure comprises inserting a needle tip of a surgical instrument intoa patient's tissue, advancing the needle tip through the tissue,monitoring an indicator of the surgical instrument while advancing theneedle tip through the tissue, and maintaining a position of thesurgical instrument in response to the indicator indicating the needletip has entered a target lumen of the patient.

In some embodiments, the surgical instrument may be operable toautomatically retract the needle tip when the needle tip has entered thetarget lumen of the patient. Additionally, in some embodiments, thesurgical instrument may include a control circuit operable to measure achange in electrical properties to determine when the needle tip hasentered the target lumen of the patient and activate the indicator toindicate the needle tip has entered a target lumen of the patient.

In some embodiments, the surgical instrument may be operable to apply anelectrical charge to a plate positioned at the needle tip. In someembodiments, the control circuit may be operable to determine when theneedle tip has entered the target lumen of the patient based on a changein electrical resistance.

In some embodiments, the control circuit may be operable to determinewhen the needle tip has entered the target lumen of the patient based ona change in resistance. In some embodiments, the target lumen may bedevoid of liquid and/or tissue. In some embodiments, liquid may bepresent in the target lumen.

According to another aspect, a surgical instrument system configured toperform any of the methods described herein is disclosed.

BRIEF DESCRIPTION OF THE DRAWINGS

The detailed description particularly refers to the following figures,in which:

FIG. 1 is a perspective view of one embodiment of a surgical instrumentsystem for use in performing a surgical procedure;

FIG. 2 is a perspective view of some of the components of the system ofFIG. 1;

FIG. 3 illustrates a circuit diagram of an electrical circuit of thesurgical instrument system of FIG. 1;

FIG. 4 is a perspective view illustrating another surgical instrumentsystem;

FIG. 4A is a partial cross-section elevation view of a detail of FIG. 4;

FIGS. 5-6 are partial cross-sectional plan views of a surgicalinstrument of the instrument system of FIG. 4; and

FIG. 7 is a circuit diagram of an electrical circuit of the surgicalinstrument system of FIG. 4;

FIG. 8 is a side elevation view of the surgical instrument of FIGS. 4-7positioned for insertion into a patient's soft tissue;

FIG. 9 illustrates the surgical instrument of FIGS. 4-7 as it enters alumen of the patient;

FIG. 10 illustrates the surgical instrument of FIGS. 4-7 after theneedle of the surgical instrument has been retracted; and

FIG. 11 is a circuit diagram of an electrical circuit for the surgicalinstrument system of FIG. 4.

DETAILED DESCRIPTION OF THE DRAWINGS

While the concepts of the present disclosure are susceptible to variousmodifications and alternative forms, specific exemplary embodimentsthereof have been illustrated by way of example in the drawings and willherein be described in detail. It should be understood, however, thatthere is no intent to limit the concepts of the present disclosure tothe particular forms disclosed, but on the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention as defined by the appended claims.

Referring now to FIGS. 1-3, a surgical instrument system 10 configuredfor insertion into the soft tissue of a patient is illustrated.Illustratively, the surgical instrument 10 may be use to form a puncturebetween the skin of the neck and the anterior wall of the trachea of apatient, but it should be appreciated that the surgical instrument 10may be used to form other punctures, incisions, or openings in thepatient's tissue. The surgical instrument system 10 includes anelongated needle body 12 that extends from a proximal end 14 to a distalend 16. A needle tip 18 configured to pierce the tissue is formed at thedistal end 16 of the body 12. The needle body 12 has a lumen orpassageway 20 extending through the ends 14, 16, as shown in FIG. 2. Inthe illustrative embodiment, a catheter may be inserted into thepassageway 20 to provide, for example, epidural anesthesia, to apatient. The surgical instrument system 10 also includes a probe 28 thatis sized to be positioned in the passageway 20 of the needle 12. Theprobe 28 is connected to an indicator 30 that is configured to notify auser that the needle tip 18 has penetrated the tissue, as described ingreater detail below.

The probe 28 includes a base 32 and a shaft 36 that extends distallyaway from the base 32 to a tip 38. In the illustrated embodiment, theshaft 36 is a cannula formed from an electrically conductive material.The tip 38 and the shaft 36 are integral, but it should be appreciatedthat in other embodiments the tip 38 and the shaft 36 may be formed asseparate components and assembled. As shown in FIG. 2, the probe 28includes a conductor plate 40 that is positioned in the distal opening42 of the tip 38. In the illustrative embodiment, the plate 40 iselectrically insulated from the tip 38 by a non-conductive film 44. Inthe illustrative embodiment, the film 44 is a ring having apredetermined thickness that surrounds the plate 40. In otherembodiments, the shaft may be formed from a non-conductive material suchas ceramic or plastic to insulate the plate. The plate 40 and the film44 cooperate to cover the opening 42 such that fluid is prevented fromentering the tip 38. When a patient's tissue contacts the conductorplate 40, electrical circuitry 50 of the system 10 is operable to detectthe change in electrical resistance caused by the contact with thetissue, as described in greater detail below.

Returning to FIG. 1, the system 10 includes a control box 52 that housesthe electrical circuitry 50, including the indicator 30. In theillustrative embodiment, the control box 52 has a power switch 54 thatmay be toggled to energize the electrical circuitry 50. A cable 56connects the electrical circuitry 50 with the probe 28.

Referring now to FIG. 3, the electrical circuitry 50 for the system 10is shown in greater detail. In the illustrative embodiment, thecircuitry 50 is operable to detect a change in electrical resistancethat is produced when the probe tip 38 exits one type of tissue andenters another type of tissue or lumen, as described in greater detailbelow.

The circuitry 50 includes a microprocessor 60 such as, for example, an8-Bit AVR 16 MHz Processor (ATMEGA32U4) commercially available fromAtmel Corporation. The microprocessor 60 is attached a circuit 62 thatalso includes various terminals 64 connected to other circuitry 50. AnI/O port 66 such as, for example, a USB port, is attached to the circuit62 to permit a user to upload software and data to, and download from,the microprocessor 60. Illustratively, the microprocessor 60, thecircuit 62, and the I/O port 66 are available in a Teensy 2.0 USB-basedmicrocontroller development system. A voltage supply includes two 3 VDCbatteries 68, the anodes of which are coupled to one terminal 70 of thepower switch 54. The other terminal 72 of switch 54 is coupled to the 5Vterminal of the circuit 62 and to the anode of a “Power Indicator” LED74. The cathode of the Power Indicator LED 74 is coupled to the cathodesof the batteries 68 and to the ground (GND) terminal of the circuit 62at the terminal 76.

The circuitry 50 also includes a “Low Battery” LED 78, which isenergized by the microprocessor 60 when battery voltage drops below apredetermined threshold. The cathode of the LED 78 is connected througha 220Ω resistor 80 to the “19” terminal of the circuit 62. The anode ofthe LED 78 is connected to the GND terminal of the circuit 62 and ananode of the indicator LED 30. The cathode of the LED 30 is connected tothe “13” terminal of the circuit 62 through another 220Ω resistor 84.

The shaft 36 of the probe 28 is coupled via a wire 90 to a groundterminal of the circuit 62. The conductor plate 40 of the tip 38 iscoupled via a wire 92 through a 4.7 kΩ resistor to the “15” terminal andthe 5 V terminal of the circuit 62.

Illustratively, the microprocessor 60 applies 4.7 V dc to the conductorplate 40 while the shaft 36 is connected to ground. The microprocessor60 is programmed to measure the resistance received by the circuit 62 ata controlled distance. In the illustrative embodiment, the distance isequal to a 0.5 millimeter gap between the conductor plate 40 and thecutting end of the shaft 36 that is created by the film 44. In theillustrative embodiment, the 0.5 millimeter gap corresponds to thethickness of the film ring 44. When the conductor plate 40 exits thepatient's tissue and enters a liquid-filled or empty target lumen, theresistance sensed at the conductor plate 40 experiences a “step” change,which the microprocessor 60 is programmed to register as indicating, forexample, that the tip 38 has penetrated a lumen. The microprocessor 60is programmed to switch the “13” terminal continuously “high,” therebyturning the indicator LED 30 continuously “on.”

When the probe tip 38 engages the patient's tissue, the resistanceexperienced by circuit changes. In the illustrative embodiment, themicroprocessor 60 is programmed to consecutively toggle the “13”terminal “high” and “low,” thereby causing the LED 30 to flash “on” and“off” to indicate to the user that the instrument system 10 is armed. Asthe needle 12 (and hence the probe 38) is advanced into the spinalcolumn, the conductor plate 40 remains engaged with the patient'stissue.

When the probe tip 38 reaches, and protrudes into, the target lumen(e.g., the interior of a patient's spinal column or trachea), theelectrical resistance in the circuit changes sharply, and themicroprocessor 60 is programmed to switch the “13” terminal continuously“high,” thereby turning the indicator LED 30 continuously “on” to informthe user to hold the needle 12 in position. The user may then remove theprobe 28 from the lumen 20 of the needle 12 while leaving the needle 12inserted into the patient's tissue. The user may then use the lumen 20to position, for example, a catheter to provide fluids to the patient.

Referring now to FIG. 4, another instrument system 110 configured forinsertion into the soft tissue of a patient is illustrated. The system110 is also configured for forming and dilating an opening in apatient's tissue is shown. The instrument system 110 includes a punctureinstrument 112 and a balloon catheter 114 that is removably coupled tothe puncture instrument. An exemplary balloon catheter for use in thesystem 110 is shown and described in U.S. patent application Ser. No.14/996,426, which is expressly incorporated herein by reference. Theinstrument system 110 may be used, for example, to create a puncture orincision in a tracheal wall of a patient and dilate the incision toreceive a prosthesis such as, for example, a tracheostomy tube to forman air passageway for the patient. For convenience, the balloon catheter114 is not shown in the illustrations of FIGS. 5-10.

Illustratively, the puncture instrument 112 may be used to form apuncture between the skin of the neck and the anterior wall of thetrachea of a patient, but it should be appreciated that the punctureinstrument 112 may be used to form other punctures, incisions, oropenings in the patient's tissue. As shown in FIG. 4, the punctureinstrument 112 includes an elongated body 120 having a proximal end 122and a distal end 124. A needle tip 126 configured to pierce the tissueis formed at the distal end 124 of the body 120. As described in greaterdetail below, the puncture instrument 112 also includes an indicator 128configured to notify a user that the needle tip 126 has penetrated thetissue and an automatic needle retraction mechanism 130 operable quicklyto retract the needle tip 126 a short distance after the needle tip 126has penetrated the tissue.

The elongated body 120 includes a handle 132 extending from the proximalend 122 to a distal handle end 134. A shaft 136 extends distally awayfrom the handle 132 to the needle tip 126. In the illustratedembodiment, the shaft 136 is a cannula formed from a metallic material.In other embodiments, the shaft may be formed from a ceramic or plasticmaterial. The needle tip 126 and the shaft 136 are integral, but itshould be appreciated that in other embodiments the needle tip 126 andthe shaft 136 may be formed as separate components and assembled.

The handle 132 illustratively includes an upper housing 140 that isconfigured to be coupled to a lower housing 142. The indicator 128includes a light source such as, for example, a plurality of lightemitting diodes (LED) 146 that is illustratively visible through anopening in the upper housing 140. The housings 140, 142 cooperate todefine a chamber in which other electrical circuitry 148 is positioned.The circuitry 148 is operable to energize the LED 146 to provide avisual output to the user. In other embodiments, the indicator 128 mayinclude other electrical circuitry to provide an audible output to theuser. The puncture instrument 112 also includes a power switch 150,which is operable to supply power to the electrical circuitry 148including LEDs 146.

As shown in FIG. 5, the electrical circuitry 148 includes a battery pack152 positioned at one end of the handle 132 and the automatic needleretraction mechanism 160, which is operable to retract the needle tip126 a short distance after the needle tip 126 has penetrated the tissue.In illustrative embodiment, the distance is 8 millimeters. A metallicplate (not shown) is positioned in handle 132 is formed from copper andis configured to provide a ground plane for the electrical circuitry148, which makes the user the ground for the electrical circuitry.

Returning to FIG. 4A, the instrument 112 also includes a conductor plate164 that is positioned in the distal opening 166 of the needle tip 126.In the illustrative embodiment, the plate 164 is a metallic shaft thatis electrically insulated from the needle tip 126 by a non-conductivefilm 168. In the illustrative embodiment, the film 44 is a cylindricalring having a predetermined thickness that surrounds the plate 40. Inother embodiments, the needle tip and/or needle shaft may be formed froma non-conductive material such as, for example, ceramic or plastic toelectrically insulate the plate. The shaft 164 and the film 168cooperate to cover the opening 166 such that fluid is prevented fromentering the needle tip 126. A wire or conductor 170 connects the shaft164 to the electrical circuitry 148, and another wire or conductor 172connects the outer cannula shaft 136 to the electrical circuitry 148.When a patient's tissue contacts the conductor plate 164, the electricalcircuitry 148 is operable to detect the change in electrical resistancecaused by the contact with the tissue, as described in greater detailbelow.

As described above, the instrument 112 includes an automatic needleretraction mechanism 160 operable to retract the needle tip 126 a shortdistance after the needle tip 126 has penetrated the tissue. As shown inFIG. 5, the needle retraction mechanism 160 includes an actuator 180. Inthe illustrative embodiment, the actuator 180 is a linear actuator suchas, for example, a solenoid, which includes an output shaft 182 operableto move along a straight line. An exemplary actuator is the Uxcella14092600ux0438 Open Frame Actuator, which is electrically-operated. Inother embodiments, the actuator may be embodied as an electric motor,electromagnet, or other electromechanical device operable to move thelocking arm 184, as described in greater detail below. As shown in FIG.5, the locking arm 184 that maintains the needle shaft 136 in anextended position.

The needle shaft 136 extends through an opening 186 defined in thedistal handle end 134, and the shaft 136 includes a proximal end 190that is secured to a mounting bracket 192 positioned in the handle 132.The mounting bracket 192 includes a cylindrical body 194 and a slideplate 196 that extends outwardly from the body 194. As shown in FIG. 6,an aperture 198 is defined at one end of the cylindrical body 194, whichreceives the proximal end 190 of the shaft 136 and provides a passagewaythrough which the connecting wire 170 passes to connect the conductorplate 164 to the other electrical circuitry 148.

As shown in FIG. 5, the edges of the slide plate 196 are received in apair of guide slots 200 defined in the handle 132, which guide themovement of the mounting bracket 192 as the needle tip 126 is retracted.A biasing element such as, for example, a spring 202 positioned betweenthe slide plate 196 and the distal handle end 134. In the illustrativeembodiment, the spring 202 is configured to bias the slide plate 196away from the distal handle end 134 and hence bias the needle tip 126 isthe retracted position.

A rod 204 extends between the cylindrical body 194 and the locking arm184. As shown in FIG. 6, the rod 204 is received in an aperture 206defined in the locking arm 184. The locking arm 184 includes a sleeve208 positioned in the aperture 206, and the rod 204 engages the sleeve208 when the needle shaft 136 is an extended position. In theillustrative embodiment, the sleeve 208 is formed from a metallicmaterial such as, for example, steel. A pivot pin 212 extends outwardlyfrom the lower housing 142 and is received in a bore defined in thelocking arm 184 near an end 216. The retraction mechanism 160 alsoincludes another biasing element, illustratively embodied as an elasticband 220, which is coupled to the shaft end 216 and the lower housing142.

When the needle shaft 136 is in its extended position and ready forinsertion into a patient's tissue, the sleeve 208 is initially engagedwith the rod 204, as shown in FIG. 6. The band 220 applies a force tothe locking arm 184 to bias in the position shown in FIG. 6 to keep therod 204 engaged with the sleeve 208, thereby resisting the force exertedby the spring 202 against the slide plate 196 and maintaining the needleshaft 136 in the extended position.

As described above, the automatic needle retraction mechanism 130 isoperable to quickly retract the needle tip 126 a short distance afterthe needle tip 126 has penetrated the tissue. To do so, the linearactuator 180 is energized to advance its shaft 182 into contact with thelocking arm 184, thereby causing the arm 184 to pivot about the pin 212as indicated by arrow 222. As the arm 184 pivots, the end of the rod 204disengages from the sleeve 208 and moves toward the center of theaperture 206. When the rod 204 disengages from the sleeve 208, thespring 202 urges the mounting bracket 192 in the direction indicated byarrow 224 in FIG. 6. As the mounting bracket 192 moves, the needle tip126 retracts away from the opposite wall of the patient's lumen.

Referring now to FIG. 7, the electrical circuitry 148 is shown. Asdescribed above, the electrical circuitry 148 is operable to detect achange in electrical resistance that is produced when the needle tip 126exits one type of tissue and enters another type of tissue or lumen, asdescribed in greater detail below. In that way, the electrical circuitry148 functions as a sensor.

The circuitry 148 includes a microprocessor 230 such as, for example, an8-Bit AVR 16 MHz Processor (ATMEGA32U4), which is commercially availablefrom Atmel Corporation. The microprocessor 230 is attached a circuit 232that also includes various terminals 234 connected to other circuitry148. An I/O port 236 such as, for example, a USB port, is attached tothe circuit 232 to permit a user to upload software and data to, anddownload from, the microprocessor 230. Illustratively, themicroprocessor 230, the circuit 232, and the I/O port 236 are availablein a Teensy 2.0 USB-based microcontroller development system. A voltagesupply includes a single 9 VDC battery 152, the anode of which iscoupled to one terminal 260 of the power switch 150. The other terminal262 of switch 150 is coupled to a voltage regulator 154 and to the anodeof a “Power Indicator” LED 264 of the LEDs 146 through a 220Ω resistor156. As shown in FIG. 7, the cathode of the Power Indicator LED 264 iscoupled to the cathode of the battery 152 and to the GND terminal of thecircuit 232. In the illustrative embodiment, the voltage regulator 154is a Texas Instruments LP2981 regulator. The voltage regulator 154 isconnected to the 5 V terminal of the circuit 232 and is configured tocondition the 9 VDC battery voltage to 5 volts.

The circuitry 148 also includes a “Low Battery” LED 270, which isenergized by the microprocessor 230 when battery voltage drops below apredetermined threshold. The cathode of the LED 270 is connected througha 220Ω resistor 272 to the “13” terminal of the circuit 232. The anodeof the LED 270 is connected to the GND terminal of the circuit 232 andan anode of the penetration indicator LED 274. The cathode of the LED274 is connected to the “13” terminal of the circuit 232 through another220Ω resistor 276. A battery monitor (not shown) may be connected toanother terminal of the circuit 232.

The shaft 136 of the instrument 112 is coupled via a wire 172 to aground terminal of the circuit 232. The conductor plate 164 in the tip126 is coupled via a wire 170 through a 68Ω resistor 280 and a 100 kΩresistor 282 to the “18” terminal and the 5 V terminal of the circuit232. The shaft 136 and the plate 164 form part of the sensor circuitused to detect when the needle tip 126 has penetrated a lumen. It shouldbe appreciated that in other embodiments the sensor circuit may includea pair of conductor plates, which are electrically isolated from oneanother, and the elongated shaft may be formed from a non-conductivematerial.

The linear actuator 180 is connected to the anodes of the LEDs 270, 274and the GND terminal of the circuit 232. The linear actuator 180 is alsoconnected to a relay switch 290, which is positioned between theactuator 180 and the terminal 262 of the switch 150. The relay switch290 is also connected to the “17” terminal of the circuit 232 and to theGND terminal, as shown in FIG. 7. The circuitry 148 also includes asnubber diode 292 that is connected between the positive and negativepoles of the actuator 180 and the power supply 152. As shown in FIG. 7,the cathode 294 of the diode 292 is connected to the relay switch 290,while the anode 296 of the diode 292 is connected to the linear actuator180 and the power supply 152.

Illustratively, the microprocessor 230 applies 4.7 VDC to the conductorplate 164 while the shaft 136 is connected to ground (e.g., the user'shand). The microprocessor 230 is programmed to measure the electricalresistance in the circuit 232 at a controlled distance. In theillustrative embodiment, the distance is equal to a 0.5 millimeter gapbetween the conductor plate 164 and the cutting end of the shaft 136that is created the non-conductive film 168. In the illustrativeembodiment, the 0.5 millimeter gap corresponds to the thickness of thefilm ring 168. During operation, when the conductor plate 164 exits thepatient's tissue and enters a liquid-filled or empty target lumen, theresistance sensed at the conductor plate 164 experiences a “step”change, which the microprocessor 230 is programmed to register asindicating, for example, that the tip 126 has penetrated a lumen. Themicroprocessor 230 is programmed to switch the “13” terminalcontinuously “high,” thereby turning the indicator LED 274 continuously“on.”

In use, the needle tip 126 of the surgical instrument 112 may be used toform a puncture in a patient's issue. As shown in FIG. 8, a surgeon orother user may align the needle tip 126 with the target lumen of thepatient's body (in this case, a patient's trachea 300) and toggle thepower switch 150 to energize the sensor circuit formed by themicroprocessor 230, the conductor shaft 164, and the outer cannula 136.Initially, when the needle tip 126 is out of contact with the patient'stissue, the circuit is open and the resistance value effectivelyinfinite.

Once the needle tip 126 is properly aligned, it may be advanced intocontact with the patient's tissue and through the anterior wall 306.When the needle tip 126 engages the patient's tissue, the circuit isclosed, and the resistance value measured by the microprocessor 230enters a predetermined range. In the illustrative embodiment, the rangeis between 1 kilo-ohm and 100 kilo-ohms. It should be appreciated thatin other embodiments other ranges of resistance values may be used. Thecontroller 230 activates a timer when the resistance value enters thepredetermined range, and after a predetermined amount of time, themicroprocessor 230 activates the LED 274. In the illustrativeembodiment, the predetermined amount of time is 200 milliseconds. Whenthe microprocessor 230 activates the LED 274 in the illustrativeembodiment, the microprocessor 230 is programmed to consecutively togglethe “13” terminal “high” and “low,” thereby causing the LED 274 to flash“on” and “off” to indicate to the user that the instrument 112 is armed.

In other embodiments, other sensors may be used to determine when theinstrument 112 is properly positioned and ready to be armed. Forexample, the instrument 112 may include a pressure sensor that measuresthe pressure on the needle tip such that when the pressure surpasses theamount of pressure associated with penetrating the patient's tissue, thecontroller would activate the indicator and arm the instrument 112. Inother embodiments, the instrument 112 may also include a cancel switchthat the user may toggle to disarm the instrument 112.

As the needle 126 is advanced into the target lumen, the conductor plate164 remains engaged with the patient's tissue. When the needle 126reaches, and protrudes into, the target lumen (e.g., the trachea 300,esophagus, or spinal column) as shown in FIG. 9, the resistance at theconductor plate 164 changes sharply. In the case of a trachea, thesensor circuit effectively opens. When the resistance value passes apredetermined threshold, and the microprocessor 230 is programmed toswitch the “13” terminal continuously “high,” thereby turning theindicator LED 274 continuously “on” to inform the user that the needle126 has reached the lumen. In the illustrative embodiment, the thresholdis 100 kilo-ohms or greater.

The microprocessor 230 is also programmed to switch the “17” terminal to“high” after a preset delay, thereby activating the relay switch 290. Itshould be appreciated that in other embodiments the preset delay may beomitted and the switch 290 activated immediately. When the switch 290 isactivated, it connects the linear actuator 180 to the battery 152,thereby energizing the actuator. As described above, the actuator 180 isoperable to advance its output shaft 182 into contact with the lockingarm 184 and causing the locking arm 184 to pivot. As the arm 184 pivots,the end of the rod 204 disengages from the sleeve 208 and moves towardthe center of the aperture 206. When the rod 204 disengages from thesleeve 208, the spring 202 urges the mounting bracket 192 in thedirection indicated by arrow 224 in FIG. 6. As the mounting bracket 192moves, the needle tip 126 retracts in direction shown in FIG. 9, awayfrom the opposite wall 302 of the patient's trachea 300 and out of theincision 304, as shown in FIG. 10.

In other embodiments, the actuator may be embodied as an electric motor,electromagnet, or other electromechanical device operable to move thelocking arm 184 within a sufficient period of time after themicroprocessor detects penetration of the lumen. In the illustrativeembodiment, the actuator 180 is operable to move the locking arm 184such that the needle is retracted in 100 milliseconds.

Referring now to FIG. 11, another embodiment of electrical circuitry 348is illustrated. The electrical circuitry 348 is identical to thecircuitry 148 described above, except for the use of two 3 VDC batteriesand the omission of a voltage regulator and snubber diode. As shown inFIG. 11, the anodes of the two 3 VDC batteries 352 are coupled to oneterminal 260 of the power switch 150. The other terminal 262 of switch150 is coupled to the 5 V terminal of the circuit 232 and to the anodeof the “Power Indicator” LED 264 of the LEDs 146.

It should be appreciated that although the concept of detecting a lumenin a patient's body has been described above in reference to surgicalinstruments that may be used to create punctures in a patient's tissue,the techniques and concepts described above may be incorporated intoother surgical instruments such that entry into a lumen or movementbetween various tissue types may be detected. For example, any surgicalcutting tool such as, for example, a cutting blade, reamer, drill, orother instrument may include circuitry to detect fluctuating levels ofelectrical resistance and thereby determine when a distal end of thecutting tool has entered a lumen. Other surgical instruments such as,for example, guides, trials, probes, and so forth may also includecircuitry to detect fluctuating levels of electrical resistance andthereby determine when a distal end of the surgical instrument hasentered a lumen.

While the disclosure has been illustrated and described in detail in thedrawings and foregoing description, such illustration and description isto be considered as exemplary and not restrictive in character, it beingunderstood that only illustrative embodiments have been illustrated anddescribed and that all changes and modifications that come within thespirit of the disclosure are desired to be protected.

There are a plurality of advantages of the present disclosure arisingfrom the various features of the method, apparatus, and system describedherein. It will be noted that alternative embodiments of the method,apparatus, and system of the present disclosure may not include all ofthe features described yet still benefit from at least some of theadvantages of such features. Those of ordinary skill in the art mayreadily devise their own implementations of the method, apparatus, andsystem that incorporate one or more of the features of the presentinvention and fall within the spirit and scope of the present disclosureas defined by the appended claims.

1. A method for performing a surgical procedure, the method comprising:inserting a needle tip of a surgical instrument into a tissue of apatient, advancing the needle tip through the tissue, monitoring anindicator of the surgical instrument while advancing the needle tipthrough the tissue, and maintaining a position of the surgicalinstrument in response to the indicator indicating the needle tip hasentered a target lumen of the patient.
 2. The method of claim 1, whereinthe surgical instrument is operable to automatically retract the needletip when the needle tip has entered the target lumen of the patient. 3.The method of claim 1, wherein the surgical instrument includes acontrol circuit operable to measure a change in electrical resistance todetermine when the needle tip has entered the target lumen of thepatient and to activate the indicator to indicate the needle tip hasentered the target lumen of the patient.
 4. The method of claim 1,wherein the surgical instrument includes a control circuit operable tomeasure a change in one or more electrical properties to determine whenthe needle tip has entered the target lumen of the patient and toactivate the indicator to indicate the needle tip has entered the targetlumen of the patient.
 5. The method of claim 4, wherein the controlcircuit is operable to apply an electrical charge to a plate positionedat the needle tip.
 6. The method of claim 1, wherein the target lumen isdevoid of liquid and of tissue.
 7. The method of claim 1, wherein aliquid is present in the target lumen.
 8. A method for performing asurgical procedure, the method comprising: energizing a sensor circuitof a surgical instrument including a needle tip configured for insertioninto a tissue of a patient, monitoring an electrical signal receivedfrom the sensor circuit, energizing an indicator in a first state whenan electrical resistance value indicated by the electrical signal isless than a predetermined value corresponding to the needle tip beingpositioned in the tissue of the patient, energizing the indicator in asecond state when the resistance value indicated by the electricalsignal is greater than a predetermined threshold corresponding to theneedle tip being positioned in a lumen of the patient, and energizing aretraction mechanism of the surgical instrument to move the needle tipaway from the lumen of the patient.
 9. The method of claim 8, furthercomprising activating a timer when the resistance value indicated by theelectrical signal is less than the predetermined value, whereinenergizing the indicator in the first state includes energizing theindicator in the first state after a predetermined amount of time haselapsed from the activation of the timer.
 10. The method of claim 8,further comprising activating a timer when the resistance valueindicated by the electrical signal is greater than the predeterminedthreshold, wherein energizing the retraction mechanism of the surgicalinstrument includes energizing the retraction mechanism of the surgicalinstrument after a predetermined amount of time has elapsed from theactivation of the timer.
 11. A method for performing a surgicalprocedure, the method comprising: energizing an indicator of a surgicalinstrument to provide a first indication to a user when a needle tip isengaged with a portion of tissue of a patient, and energizing theindicator to provide a second indication different from the firstindication in response to the needle tip exiting the portion of tissue.12. The method of claim 11, further comprising automatically retractingthe needle tip in response to the needle tip exiting the portion oftissue.
 13. The method of claim 11, wherein energizing the indicator toprovide the second indication different from the first indication inresponse to the needle tip exiting the portion of tissue comprisesenergizing the indicator when the needle tip has entered a target lumenof the patient.
 14. The method of claim 11, wherein energizing theindicator to provide the second indication different from the firstindication in response to the needle tip exiting the portion of tissueincludes energizing the indicator when the needle tip has enteredanother portion of the patient.